Medical Safety Processes and Projects Manager

Job Description Summary

This role combines responsibilities in Medical Safety Operations (addressing pharmacovigilance (PV) needs) with Project Management activities. Reporting to the Head Medical Safety (MS) Processes & Projects, the MS Processes and Projects (MS P&P) Manager is responsible for planning of deliverables associated with MS owned processes and other key initiatives impacting MS.
The MS P&P Manager will lead and provide operational planning/execution support to assigned process development/improvement activities related to Medical Safety provisioned, led and/or supported by MSO.
The MS P&P Manger is accountable to ensure adequate quality and compliance in relation to process executions (with or without involvement of IT systems) in Medical Safety through driving their assigned initiatives as well as inspection readiness via process (and where applicable, IT systems) maintenance and/or improvements.

Job Description

Major Activities

1. Lead and coordinate Medical Safety (MS) owned/supported processes (and IT systems) with support of Process and Projects Lead (as applicable) in conducting regular reviews to identify improvement needs (e.g., optimizations, retirements, automations, etc.) which can be addressed through projects and support development of the appropriate business case; projects should result in improved performance (incl. quality) and/or compliance (considering internal and external/regulatory requirements).

2. Exhibit leadership and accountability for assigned initiatives provisioned, led or supported by Medical Safety Operations (MSO) to safeguard deliverables, quality as well as timelines incl. necessary support (e.g., deputy identification for processes and appropriate knowledge transition).

3. Support or lead compliance in assigned activities and challenge 'as-is' for continuous improvement and assure inspection readiness

4. Support or lead proactive identification of risks / issues via close monitoring of assigned processes (incl. conductance of effectiveness checks and monitoring of metrics)

5. Provide subject matter expertise, guidance & support for process creation and/or updates incl. management of Medical Safety related process issues (both internal and external).

6. Support Head MS P&P in communications related to process changes and other key initiatives as applicable.

7. Support team in creating transparency and sharing key learnings and best practices for continuous processes, projects and/or departmental improvement

8. Provide support and/or deputize for MS P&P Lead as needed (e.g., process ownerships)

9. Support readiness preparations for PV Audits/Inspections and provide support during PV Audits/Inspections incl. act as SME where applicable.

10. Foster strong relationships with key internal stakeholders and customers through demonstrating company values (inspired, curios, unbossed and self-aware) in Medical Safety.

11. Ensure completion of applicable trainings in a timely manner.

Key Performance Indicators

• Efficient projects and process maintenance based on assignment, priorities/importance and requirements.

• Timeliness of deliverables according to established directives.

• Quality of work delivered (attention to important details, thoroughness, scientifically sound).

• Moderate level of independence.

• Value of contribution as a Subject Matter Expert for Medical Safety function work streams and initiatives.

• Effectiveness and efficiency of management & execution of PS&PV work streams and initiatives.

Impact on the organization:

Ensures value generation for Medical Safety and PS & PV in general

through an effective and efficient operational execution and support of

processes and projects owned by MS and other functions (as applicable).

Education:

• Advanced degree or equivalent education in Healthcare /

Life Sciences is preferred, such as, MD, MBBS, MSc,

Pharm D, PhD

Languages:

• Fluent in spoken and written English

Experience: Required professional experience:

• At least 6 years (of at least 3 years in a global role) of

project management (at least 2 years as a project leader)

and/or Process ownership experience in a pharmaceutical

or healthcare consulting setting, preferably in drug safety

(i.e., Pharmacovigilance), clinical research, or regulatory

affairs

• Solid knowledge in drug safety related processes (incl.

authoring procedural documents, workflow design)

• Proven ability to work with cross-functional teams in

initiatives

• Results-driven, self-starter with proactive working style,

committed and accountable, transparent working style

also under pressure

• Quality oriented

• Proven ability for clear and concise communication

tailored to a diverse audience and effective cross

functional collaboration, stakeholder engagement and

teamwork

• Very good planning, organizational and computer skills

• Sense of urgency and ability to manage multiple priorities

under a changing environment

• Good negotiation, conflict resolution, decision making,

problem solving, and presentation skills

Skills Desired

Clinical Research, Clinical Trials, Functional Teams, Literature Review, Medical Records, Process Safety, Regulatory Compliance, Safety Science

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